Wednesday, November 22, 2017

Quality Audit: Introduction, Types and Procedure

Auditing in simple terms could be defined as inspection of a process or a system to make sure that it complies with the requirements...

In-Process Checks (Stage – Dry Syrup Packing)

In case of In-process during stage of packing weight check is very important, following are the procedure for the same: Collect one bottle...

In-Process Checks During Blister Packaging

During Blister packing of solid oral dosage followings are the In-process checkpoints: After running the machine in initial, a piece of blister foil to...

Qualification of Water System

Earlier pharmaceutical industries used to rely on one time procedures that had a severe impact on the formulations resulting in product recalls often and...

Introduction to Water for Pharmaceutical Purpose

Water is an integral part of human body; likewise it is also inseparable when it comes to pharmaceutical industry.  It as an essential raw...

Corrective and Preventive Actions…Basic approach

Corrective and Preventive Actions CAPA is a fundamental management tool that should be used in every quality system.  This program provides a simple step by...

Site Master File (SMF)

SMF (Site Master File) as the name indicates is a document that provides authentic information regarding the site of a pharmaceutical manufacturing plant. The...

Process FMECA in Pharmaceutical Manufacturing

Process Failure Mode and Effective Analysis in Pharmaceutical Manufacturing The objective of this study is to explore the understanding of Process Failure Mode and Effective...

Hold Time Study …..current approach

Hold Time Study Approach...... It is an expectation of regulatory organizations that companies establish and monitor clean and dirty equipment hold times for manufacturing equipment...

SOP on Quality Risk Management

1.0 Objective To describe the procedure for management of risks, arising from different operations, activities and discrepancies. 2.0 Scope This Standard Operating Procedure is applicable for the...